Adoption of decentralized trial elements in cancer clinical trials supporting FDA approvals during COVID-19.

Abstract

e13802 Background: The COVID-19 pandemic significantly disrupted the conduct of cancer clinical trials. Facilitated by emergency FDA guidance, many sponsors integrated decentralized clinical trial (DCT) elements to prioritize patient safety and maintain access. The FDA’s Oncology Center of Excellence, in collaboration with the Clinical Trials Transformation Initiative (CTTI), assessed the adoption of DCT elements in registrational cancer clinical trials conducted during the pandemic that resulted in an FDA approval. Methods: CTTI sent trial sponsors a recruitment email with a link to an online survey and the name of the trial that resulted in an FDA approval. Sponsors were asked to select the DCT elements used in that trial prior to and in response to the pandemic, challenges faced when implementing these approaches, and the likelihood of using the approaches in the future. Data were collected from December 6, 2022 to January 17, 2023. Descriptive statistics were used to summarize sponsor responses. Results: Out of 52 eligible studies, 19 surveys were completed from 13 unique sponsors (37%; 12 pharmaceutical companies and 1 chose not to disclose). Sixty-three percent of sponsors identified as a large pharmaceutical company with a market cap of over $10 billion. The majority of cancer clinical trials (89%) occurred both in the United States and abroad, with almost all sponsors (95%) incorporating at least one DCT element during the pandemic. The most widely adopted DCT elements were remote site monitoring (89%), telemedicine (68%), remote laboratory assessments (63%), remote distribution of investigational product (58%) and local imaging assessments (47%). The main challenges in implementing DCT elements included site institutional policies (83%), site challenges with technology adoption (61%) and site regulatory restraints (56%). Many sponsors intend to incorporate some degree of decentralization in future cancer clinical trials, with remote site monitoring (95%), remote collection of patient-reported outcomes (68%), telemedicine (68%), and electronic informed consent (58%) being deemed "highly likely" or "likely" for future adoption. Conclusions: The COVID-19 pandemic accelerated the use of DCT elements in cancer clinical trials. This study represents the first systematic evaluation of the use of DCT elements in cancer clinical trials intended for regulatory submission and provides proof of concept that cancer trials with DCT elements can generate data suitable for FDA review and marketing approval. The appropriate use of DCT elements holds promise to expand clinical trial access and reduce patient burden. Further characterization and mitigation of clinical site-level challenges is warranted to encourage continued adoption of DCT elements in cancer clinical trials.